Solutions
PathWise provides Quality Systems training and consulting for FDA and ISO regulated industries. Over more than a decade, we have provided best-practices for QSR’s, cGMP’s, CAPA, ISO 14971, ISO13485, and other issues impacting the Life Sciences industry.
Whether you’re facing an FDA warning letter, an uphill battle against the findings of a recent Audit, or wanting to improve quality and compliance, PathWise can help. We’ve worked with many companies in the Medical Device and Pharmaceutical device industries to solve problems such as:
- Procedures not being correctly defined and/or documented.
- Difficulty finding the root cause of a non-conformance – resulting in repeat investigations.
- Communicating quality procedures beyond the QA department.
- Investigations remaining open longer than policy allows.
PathWise not only provides an outside perspective to these issues, we bring proven best-practices, tools, and processes. We’ve studied the best of the best in the life sciences field, and bring an intimate knowledge of the FDA regulation.
Learn more about our solutions for Medical Device or Pharmaceutical companies.
Through training in PathWise Project Success managers learned a process for the selection and approval of projects. Team leaders and team members acquired the skills to accomplish projects on time and within scope.
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